Primary Device ID | 00763000497040 |
NIH Device Record Key | bd54c43e-6015-4acd-90c7-7a91b07f7091 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PTEYE |
Version Model Number | PTEYE |
Company DUNS | 835465063 |
Company Name | MEDTRONIC XOMED, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000497040 [Primary] |
QDF | Parathyroid autofluorescence detection device |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-25 |
Device Publish Date | 2023-09-16 |
00763000497057 | PROBE PTEYE-1 FIBER OPTIC |
00763000497040 | CONSOLE PTEYE |
00763000497163 | CONSOLE PTEYE-RF REFURBISHED |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PTEYE 88911798 not registered Live/Pending |
AI BIOMED CORP. 2020-05-12 |